Del Mar Sánchez Suárez María, Martín Roldan Alicia, Rojo-Tolosa Susana, Jiménez-Morales Alberto, Morales-García Concepción
Pharmacy Service, Hospital de Baza, Granada, 18800, Spain.
Pharmacy Service, University Hospital Virgen de las Nieves, Granada, 18014, Spain.
Sci Rep. 2025 Jul 1;15(1):21777. doi: 10.1038/s41598-025-07275-0.
Asthma is a prevalent chronic respiratory condition. Most patients can manage their symptoms with standard treatments but approximately 5-10% experience severe uncontrolled asthma (SUA), characterized by persistent symptoms and frequent exacerbations despite optimized therapy. This retrospective, observational, multicentre study conducted in southern Spain aimed to evaluate the effectiveness of benralizumab in patients with SUA and identify predictive markers of response. A total of 99 patients were selected. Mean age of participants was 63 ± 15.3 years. Results showed that 79.8% of patients achieved a 50% reduction in oral corticosteroid (OCS) use, 81.8% experienced at least a 50% reduction in exacerbations, and 75.7% had a ≥ 10% improvement or maintained %forced expiratory volume in 1 s (FEV) above 80%. Significant improvements were observed in lung function, asthma control, and a reduction in eosinophil levels (p < 0.001). The frequency of exacerbations and OCS cycles significantly decreased (p < 0.001), and ACT scores improved. The presence of concomitant COPD was associated with a lower probability of lung function improvement, highlighting the importance of phenotypic characterization in treatment response. Importantly, higher baseline eosinophil counts were associated with better clinical outcomes, suggesting their potential as predictive biomarkers. This study supports the real-world effectiveness of benralizumab in reducing OCS dependency, exacerbations, and enhancing pulmonary function in patients with severe uncontrolled asthma.
哮喘是一种常见的慢性呼吸道疾病。大多数患者可以通过标准治疗控制症状，但约5%-10%的患者患有严重难治性哮喘（SUA），其特征是尽管进行了优化治疗，仍有持续症状和频繁发作。这项在西班牙南部进行的回顾性、观察性、多中心研究旨在评估贝那利珠单抗对SUA患者的疗效，并确定反应的预测标志物。共选择了99例患者。参与者的平均年龄为63±15.3岁。结果显示，79.8%的患者口服糖皮质激素（OCS）用量减少了50%，81.8%的患者发作次数至少减少了50%，75.7%的患者一秒用力呼气容积（FEV）改善≥10%或维持在80%以上。肺功能、哮喘控制和嗜酸性粒细胞水平降低均有显著改善（p<0.001）。发作频率和OCS周期显著降低（p<0.001），ACT评分改善。合并慢性阻塞性肺疾病（COPD）与肺功能改善的可能性较低相关，突出了表型特征在治疗反应中的重要性。重要的是，较高的基线嗜酸性粒细胞计数与更好的临床结果相关，表明它们作为预测生物标志物的潜力。这项研究支持了贝那利珠单抗在减少严重难治性哮喘患者对OCS的依赖、发作次数和增强肺功能方面的实际疗效。
